Safety and Preliminary Efficacy of FAB117-HC in Patients With Acute Traumatic Spinal Cord Injury

About this trial

This trial is recruiting individuals with acute thoracic (chest area) spinal cord injuries to test the safety and effect of a stem cell application. Stem cells have been reported in animal studies to limit secondary cell damage and promote nerve regeneration. This study investigates the use of adipose (fat)-derived (mesenchymal) stems cells. Decompression and stabilization surgery (DSS) of the spinal column is routinely performed after SCI, and it is at this time the stem cells (derived from fat cells) can also be injected into the injured spinal cord. The study has two focuses: cell injection versus a control group (no cells), and a lower dose of cells versus a higher dose. If selected participants will undergo routine DSS within 5 days after SCI. Participants will then either receive the stem cell injection or no stem cell injection; neither participant nor investigator will know the treatment administered. In the follow-up period, participants will undergo neurological testing for any changes in sensory and motor function.